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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 090951

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NDA 090951 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Rx, Epic Pharma Llc, Pharmobedient, Somerset Theraps Llc, and Sun Pharm Inds, and is included in six NDAs. It is available from one supplier. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for 090951

Tradename:	EPINASTINE HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	epinastine hydrochloride
Patents:	0

Pharmacology for NDA: 090951

Mechanism of Action	Adrenergic Agonists Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Suppliers and Packaging for NDA: 090951

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090951	ANDA	Somerset Therapeutics, LLC	70069-008	70069-008-01	1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Oct 31, 2011	TE:	AT	RLD:	No

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